Aceto US, L.L.C recalls a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packa…

Recall date

June 24, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

H-0441-2025

FDA classification

Class III

Brand / firm

Aceto US, L.L.C

Sold / distributed

NJ, NC, CA, UT, MT, FL, AZ, NC, NY

Why it was recalled

4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45%

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium Orotate 9% packaged in HDPE Liner in a 25kg carton